Deviation in the Standard of Medical Care for Failing to Provide Informed Consent

Evaluate breaches in the standard of care by analyzing your fact pattern and answering the questions below to determine whether or not there has been a Deviation in the Standard of Medical Care for Failing to Provide Informed Consent

Answer the following questions to find out if the standard of care was followed for your case.

Did the clinician explain the medical condition to the patient?YesNoAnswer unknownWhy is this important?The clinician has a legal and ethical responsibility to provide adequate medical information to the patient, to enable the patient to make educated decisions about their medical care.(2007) 66 GAINEN 2 213

Did the clinician explain the risks of the proposed treatment? Why is this important?Answer this question The modern legal framework of informed choice requires that information be presented at what a reasonable, prudent person in the patient's position would find material to know. This is the reasonable person standard. (2004) 85 IJGYOB 3 309-314

Were all the complications of the procedure explained and documented? Why is this important?Answer this question Even when the treatment rendered by the physician comports with the standard of care, a patient may bring a suit if the physician did not obtain the required informed consent. (2004) 85 IJGYOB 3 309-314

Were treatment-related statistics, such as success and failure rates, disclosed and documented? Why is this important?Answer this question Disclosure of treatment success and failure rates fits within the framework of negligence law, since it requires practitioners to discharge their professional duty to maintain contemporary knowledge in their field of specialization. (2004) 85 IJGYOB 3 309-314

Did the clinician explain and document the risks involved with refusing the proposed treatment? Why is this important?Answer this question The patient, who refuses a procedure or any medical treatment, must be offered a detailed explanation of the risks associated with declining the proposed procedure. (2007) 66 GAINEN2 213-218

Was the patient made aware that the procedure was irreversible, and was this fact documented? Why is this important?Answer this question The potential irreversibility of a procedure needs to be explained to the patient before it is undertaken. (2011) 115 IJGYOB 1 88

Was the patient made aware of the personnel involved in the procedure? Why is this important?Answer this question The clinician needs to disclose all the personnel who will be participating in the procedure, and their respective roles. This includes all residents, students, nurse practitioners, and equipment representatives. (2007) 66 GAINEN 2 213-218

Was the possible necessity for additional procedures discussed and documented? Why is this important?Answer this question The clinician needs to inform patients of any additional procedures that may be necessary to achieve a successful outcome. Click here for additional information at MDConsult.com

Was the possibility for the need of a blood transfusion discussed and documented in the medical records? Why is this important?Answer this question Hemotherapy is not free of risks. Obtaining an informed consent for a transfusion prior to the onset of any medical treatment is required. (2007) 66 GAINEN 2 213-218

Did the clinician take the necessary steps to ensure that the patient understood the proposed treatment? Why is this important?Answer this question Information needs to be provided in terms that the patients and/or their families can easily understand. Interpreters need to be used, when a language barrier exits. (2007) 66 GAINEN 2 213-218

Was the patient’s capacity to make medical decisions assessed? Why is this important?Answer this question In order for consent to treatment to be valid in the eyes of the law, it must be based on a defined amount and quality of information, must be given voluntarily, and must be given by someone who has the legal capacity to consent. Click here for additional information at ClinicalKey.com

Was the patient deemed incompetent of decision making? Why is this important?Answer this question The duty of informed consent extends to a patient’s proxy or surrogate decision maker, if the patient is clinically incompetent to provide consent. The most significant exception to the informed-consent doctrine is for emergency situations. Generally, when a patient lacks legal capacity to make decisions or is unconscious and immediate medical care is required lest the patient suffer irreparable harm, informed consent need not be obtained prior to rendering treatment. (2002) 16 EHOCNA 6 1365-1380

Did the clinician document the medical record and sign the “informed consent” form? Why is this important?Answer this question The informed consent discussion and its documentation need to be performed by the physician who will be performing the procedure. The physician needs to document in the medical records, the date and time of the discussion including a written summary of what was said and to whom, making note of relatives, friends, or support staff such as nurses or interpreters who are present. (2002) 16 EHOCNA 6 1365-1380

Was the informed consent given voluntarily by the patient or the caregiver (next of kin)? Why is this important?Answer this question The essential element of informed consent is that the consent be voluntary. For the consent to be valid, it must be given voluntarily and free from direct or implied coercion. Click here for additional information at ClinicalKey.com

Did the clinician document the patient's refusal of treatment? Why is this important?Answer this question Documentation is particularly important when patients refuse intervention. (2007) 66 GAINEN 2 213-218

In the case of an emergency, did the clinician record and document the facts determining the patient’s inability to provide consent? Why is this important?Answer this question When informed consent cannot be obtained due to an emergency situation, physicians need to document in the written record what facts were considered in determining the patient’s ability to process information and make reasonable decisions. (2007) 66 GAINEN 2 213-218